Delving into the Latest Updates on Follitropin alfa biosimilar(Suzhou Alphamab Co. Ltd.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Hormone

Synonyms

促卵泡激素α生物类似药 (苏州康宁杰瑞)

+ [2]

Target

FSHR

Action

agonists

Mechanism

FSHR agonists(Follicle-stimulating hormone receptor agonists)

Therapeutic Areas

Urogenital Diseases

Active Indication-

Inactive Indication

Infertility, Female

Originator Organization

Alphamab Jilin Co., Ltd.

Active Organization

Alphamab Jilin Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

Regulation-

Login to view timeline

Structure/Sequence

Sequence Code 3246

The sequence is quoted from: *****

Sequence Code 3253

The sequence is quoted from: *****

主要研究目的以康宁杰瑞（吉林）生物科技有限公司提供的重组人促卵泡激素注射液（代号：LM001）为受试制剂，按有关生物等效性试验的规定，以默克雪兰诺生产的重组人促卵泡激素注射液果纳芬为参比制剂，进行人体药代动力学比对研究。次要研究目的观察受试制剂LM001和参比制剂果纳芬®在健康受试者中的安全性。

[Translation]

Main research purpose The recombinant human follicle stimulating hormone injection (code: LM001) provided by Alphamab Oncology (Jilin) Biotechnology Co., Ltd. was used as the test preparation. According to the relevant provisions of the bioequivalence test, the recombinant human follicle stimulating hormone injection Gonal-f produced by Merck Serono was used as the reference preparation for a human pharmacokinetic comparison study. Secondary research purpose To observe the safety of the test preparation LM001 and the reference preparation Gonal-f® in healthy subjects.

Start Date20 Oct 2022

Sponsor / Collaborator

Alphamab Jilin Co., Ltd.

CTR20181723

/ CompletedPhase 3

评价重组人促卵泡激素注射液（LM001）在体外受精-胚胎移植中行控制性超促排卵的有效性和安全性的Ⅲ期临床试验

[Translation] Phase III clinical trial to evaluate the efficacy and safety of recombinant human follicle-stimulating hormone injection (LM001) in controlled ovarian hyperstimulation during in vitro fertilization-embryo transfer

试验主要目的为评价重组人促卵泡激素注射液（LM001）在体外受精-胚胎移植中行控制性超促排卵的女性受试者中的有效性。次要目的为评价重组人促卵泡激素注射液（LM001）在体外受精-胚胎移植中行控制性超促排卵的女性受试者中的安全性和耐受性以及免疫原性。

[Translation]

The primary purpose of the trial is to evaluate the effectiveness of recombinant human follicle-stimulating hormone injection (LM001) in female subjects undergoing controlled super ovulation during in vitro fertilization-embryo transfer. The secondary purpose is to evaluate the safety, tolerability and immunogenicity of recombinant human follicle-stimulating hormone injection (LM001) in female subjects undergoing controlled super ovulation during in vitro fertilization-embryo transfer.

Start Date07 Jun 2019

Sponsor / Collaborator

Alphamab Jilin Co., Ltd.

100 Clinical Results associated with Follitropin alfa biosimilar(Suzhou Alphamab Co. Ltd.)

Login to view more data

100 Translational Medicine associated with Follitropin alfa biosimilar(Suzhou Alphamab Co. Ltd.)

Login to view more data

100 Patents (Medical) associated with Follitropin alfa biosimilar(Suzhou Alphamab Co. Ltd.)

Login to view more data

109

Literatures (Medical) associated with Follitropin alfa biosimilar(Suzhou Alphamab Co. Ltd.)

01 Aug 2025·Journal of Pharmaceutical and Biomedical Analysis

Development and characterisation of a method for determining N-terminal heterogeneity in the human recombinant follitropin β-subunit

Article

Author: Zhang, Xiaoming ; Hu, Xinyue ; Li, Yi ; Liang, Chenggang ; Han, Xuezhi ; Li, Jing ; Lv, Ping ; Sun, Yue ; Wang, Lvyin

Recombinant human follicle-stimulating hormone (rhFSH) consists of α- and β subunits linked by non-covalent bonds. Both subunits exhibit N-terminal heterogeneity, with the β-subunit exhibiting heterogeneity to a greater extent. In this study, we developed a comprehensive method for assessing β-subunit N-terminal heterogeneity based on a previously developed peptide mapping approach. The new method, which includes optimised sample preparation and reversed-phase high-performance liquid chromatography, facilitated the separation of integrated (NSCELTNITIAIEK) βL1 and truncated (CELTNITIAIEK) βL1 forms. The identity of the separated integrated and truncated forms was confirmed via tandem mass spectrometry. Optimised sample preparation streamlined the process by simultaneously performing trypsin digestion (with calcium chloride enhancement) and PNGase F deglycosylation for a total preparation time of just 1 day. The enzymatic digestion and sample preparation processes underwent several evaluations, including scaled-up sample preparation, sample preparation variability assessment and extended incubation stability studies. The sample preparation process demonstrated excellent robustness in all evaluations. Results consistently showed approximately 50 % N-terminal truncation of two amino acids in the β-subunit across different manufacturers' samples, highlighting the utility of the method in assessing the batch-to-batch consistency and comparability of biosimilar products. This integrated approach combines peptide mapping and N-terminal heterogeneity analysis into a single, efficient workflow, thereby significantly enhancing quality control processes and enhancing the safety and efficacy of recombinant FSH products.

28 Feb 2025·Endocrinology and Metabolism

Development of a Long-Acting Follicle-Stimulating Hormone Using Serum Albumin Fab-Associated Technology for Female Infertility

Article

Author: Cho, Yoon Hee ; Han, Jaekyu ; Song, Moo Young ; Lee, Soohyun ; Cha, Sang-Hoon ; An, Jeongsuk ; Lee, Kyungsun ; Kang, Min Jeong ; Chi, Susan ; Lee, So Jeong ; Chi, Hyunjin ; Kim, Daham ; Yun, Bo Hyon ; Lee, Eun Jig

Background: Recombinant human follicle-stimulating hormone (rhFSH) is commonly used to treat female infertility, but its short half-life necessitates multiple doses. Even corifollitropin alfa, with an extended half-life, requires supplementary injections of rhFSH after 7 days. This study aimed to develop and evaluate a long-acting follicle-stimulating hormone (FSH) formulation using anti-serum albumin Fab-associated (SAFA) technology to avoid additional injections and enhance ovarian function.Methods: SAFA-FSH was synthesized using a Chinese hamster ovary expression system. Its biological efficacy was confirmed through assays measuring its ability to stimulate cyclic adenosine monophosphate (cAMP) production, estradiol synthesis, and the expression of human cytochrome P450 family 19 subfamily A member 1 (hCYP19α1) and human steroidogenic acute regulatory protein (hSTAR) in human ovarian granulosa (KGN) cells. To evaluate the effects of SAFA-FSH, we compared its impact on serum estradiol levels and ovarian weight increase with that of rhFSH in Sprague-Dawley (SD) rats using the modified Steelman-Pohley test.Results: The results indicated that SAFA-FSH induces cAMP synthesis in KGN cells and upregulates the expression of hCYP19α1 and hSTAR in a dose-dependent manner. Female SD rats, aged 21 days, receiving daily subcutaneous human chorionic gonadotropin injections for 5 days exhibited a significant increase in serum estradiol levels and ovarian weight when administered SAFA-FSH on the first day or when given nine injections of rhFSH over 5 days. Notably, the group receiving SAFA-FSH on the first and third days demonstrated an even greater rise in serum estradiol levels and ovarian weight.Conclusion: These findings suggest that SAFA-FSH presents a promising alternative to current rhFSH treatments for female infertility. However, further research is essential to thoroughly assess its safety and efficacy in clinical contexts.

01 Jul 2023·Best Practice & Research Clinical Obstetrics & Gynaecology

WITHDRAWN:Â Effectiveness of recombinant human follicle-stimulating hormone (r-hFSH): recombinant human luteinizing hormone versus r-hFSH alone in assisted reproductive technology treatment cycles among women aged 35–40 years: A German database study

Review

Author: Krussel, J S ; Verpillat, P ; Hayward, B ; D'Hooghe, T ; Bielfeld, A P ; Fischer, R ; Lispi, M ; Chuderland, D ; Schwarze, J E

This non-interventional study compared the effectiveness of recombinant human follicle-stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH) (2:1 ratio) versus r-hFSH alone for ovarian stimulation (OS) during assisted reproductive technology treatment in women aged 35-40 years, using real-world data from the Deutsches IVF-Register (D·I·R). Numerically higher clinical pregnancy (29.8% [95% CI 28.2, 31.6] vs. 27.8% [26.5, 29.2]) and live birth (20.3% [18.7, 21.8] vs. 18.0% [16.6, 19.4]) rates were observed with r-hFSH:r-hLH versus r-hFSH alone. The treatment effect was consistently higher for r-hFSH:r-hLH compared with r-hFSH alone in terms of clinical pregnancy (relative risk [RR] 1.16 [1.05, 1.26]) and live birth (RR 1.16 [1.02, 1.31]) in a post-hoc analysis of women with 5-14 oocytes retrieved (used as a surrogate for normal ovarian reserve), highlighting the potential benefits of r-hFSH:r-hLH for OS in women aged 35-40 years with normal ovarian reserve.

100 Deals associated with Follitropin alfa biosimilar(Suzhou Alphamab Co. Ltd.)

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	G03GA06	DB00066

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Infertility, Female	Phase 2	China	Alphamab Jilin Co., Ltd.	23 Dec 2021

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00989781 (CTgov)	Not Applicable	Polycystic Ovary Syndrome	41	Glucose+Adrenocorticotropin+recombinant human chorionic gonadotropin+Recombinant human follicle stimulating hormone+Dexamethasone (Normal Women)	brisphaewu(jofcbuzkoh) = bnwzvgtxmx dortfouxhf (srzpwuvbdy, bnaecwwhuw - acyvuufvnk) View more	-	17 Oct 2017
				Glucose+Adrenocorticotropin+recombinant human chorionic gonadotropin+Recombinant human follicle stimulating hormone+Dexamethasone (PCOS Women)	wvfzvnfmct(zrjcqwpocf) = wtwdaccnlx lgncclolps (uncssutfkh, gmyhfmizsl - uzqcvgqqiw) View more
NCT01185704 (ATTAC-PCO, CTgov)	Phase 3	Polycystic Ovary Syndrome	136	Cetrorelix acetate+Recombinant Human Choriogonadotropin (r-hCG)+Recombinant human follicle stimulating hormone (r-hFSH) (Day 1 Protocol)	qdqwposfky(mkvzteglkt) = ghkzvxwcin jruozujgpf (qjbbymonnp, ucogoazyfc - ykgxlobgna) View more	-	03 Jul 2013
				Cetrorelix acetate+Recombinant Human Choriogonadotropin (r-hCG)+Recombinant human follicle stimulating hormone (r-hFSH) (Day 7 Protocol)	qdqwposfky(mkvzteglkt) = ivrdjjrrig jruozujgpf (qjbbymonnp, vnxsvhaiwe - xbldkslxyr) View more

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

login

or

view full example data